Lykos Therapeutics has completed a European Phase II study (MP18) evaluating midomafetamine (MDMA) capsules for post-traumatic stress disorder (PTSD).

MP18 is an open-label, multicenter feasibility study of investigational MDMA capsules used in combination with psychological intervention (MDMA-assisted therapy) for adults with PTSD.

This marks a significant milestone in the company’s European programme, following the successful completion of Phase III trials in the US and the submission of a new drug application to the US Food and Drug Administration (FDA).

The MP18 study involved 21 participants across multiple sites in the Netherlands, the UK, Czech Republic, Norway and Germany.

It also included an optional fMRI sub-study to assess brain activity changes in individuals with PTSD.

The capsules are currently under FDA review and have not yet been approved.

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Lykos is also exploring the potential of investigational midomafetamine in other therapeutic indications.

Lykos Therapeutics CEO Amy Emerson said: “Given the substantial need for new treatment options for individuals with mental health conditions in Europe, the completion of this Phase II study is an important step to helping address unmet needs outside the US.

“By pursuing FDA approval of MDMA-assisted therapy first, we believe the learnings will be beneficial as we determine our regulatory strategy in the United Kingdom and Europe. We are exploring different avenues to bring MDMA-assisted therapy to market outside the US.”

In February, the US FDA accepted Lykos’ new drug application (NDA) for midomafetamine capsules used in combination with psychological intervention.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of 11 August 2024.

Leiden University Medical Center and lead investigator of the study, psychiatry professor Eric Vermetten, said: “Successful completion of this Phase II study in Europe is an important step to build on the body of evidence evaluating the efficacy and safety of MDMA-assisted therapy in the US where this novel therapeutic approach now is under FDA review.

“There is an urgent need for new and effective evidence-based treatments for PTSD in Europe where the reported PTSD prevalence is up to 6.7%.”